Posted by Michael Wonder on 21 Sep 2018
Tetraphase Pharmaceuticals announces adoption of Commission decision granting marketing authorisation approval in the European Union for Xerava (eravacycline) for the treatment of complicated intra-abdominal infections
20 September 2018 - Broad product label for treatment of complicated intra-abdominal infections.
Tetraphase Pharmaceuticals today announced that the European Commission has adopted the Decision granting marketing authorisation for Xerava (eravacycline) for injection for the treatment of complicated intra-abdominal infections (cIAI) in adults in the European Union. In clinical trials, Xerava was well-tolerated and achieved high clinical cure rates in patients with cIAI, demonstrating statistical non-inferiority to two widely used comparators – ertapenem and meropenem.
The European Commission approval follows the positive opinion issued by the CHMP and allows Tetraphase to market Xerava in all countries in the European Union as well as Iceland, Liechtenstein and Norway. The decision was based on a comprehensive data package which included data from the Company’s phase 3 clinical trials investigating Xerava in patients with cIAI compared to ertapenem and meropenem.
